So, belzutifan is a HIF-2 inhibitor that has been recently approved for the treatment of patients with metastatic clear cell renal cell carcinoma following prior lines of therapy. And this is based on large trials evaluating this drug. And we thought to evaluate the safety and efficacy of Belzutifan using the International Metastatic RCC Database Consortium, which includes real-world data...
So, belzutifan is a HIF-2 inhibitor that has been recently approved for the treatment of patients with metastatic clear cell renal cell carcinoma following prior lines of therapy. And this is based on large trials evaluating this drug. And we thought to evaluate the safety and efficacy of Belzutifan using the International Metastatic RCC Database Consortium, which includes real-world data. And so we looked at patients who received Belzutifan monotherapy across different lines of therapy. We grouped them into two groups, patients who were in the second and third line of treatment, and patients who received Belzutifan in the fourth line or above. And so we looked at efficacy parameters. These corresponded to overall response rate, disease control rate, also treatment duration, and overall survival. We also looked at safety parameters and these included adverse events, obviously, need for dose reduction and discontinuation of the drug due to adverse events. Overall, we had around 70 patients. Within the second to third line of treatment, and this is the first subgroup of patients, we had around 44 patients. And the second group of patients, so fourth line and above, we had around 30 patients. And looking at the outcomes of those patients who received Belzutifan monotherapy, we first in terms of treatment duration that the median treatment duration was around seven months but it was 11 months for patients who had received Belzutifan in the second to third line of treatment versus lower than seven months so around like six months or five months for patients who received Belzutifan in the fourth line or more. Similarly for overall survival, the 12-month overall survival rate was 64% in the entire cohort. Once certified by some groups of treatment, we saw that it reached around 80% in patients treated in the second or third line setting versus 40% in patients treated in the fourth line setting or above. And it’s important to know that these patient populations had overall, within the subgroups of treatment, had overall similar baseline characteristics, meaning similar age, similar distribution of IMDC risk groups too. And finally, the last parameter or set of parameters of efficacy are disease control rate and overall response rate. And looking at overall response rate, we saw just also similarly a better overall response rate, around 14% in patient treatment within the second, third line setting versus around 7% to 8% in patients in fourth line setting or above. Finally, in terms of the safety, so obviously many patients experience adverse events. The most notable one was anemia and overall 38% of patients needed dose reduction because of adverse events. Again, the most common cause in the setting being anemia and or related hypoxia. And so we hope this data helps really to shed more light on the efficacy of Belzutifan, show how outcomes differ based on the line of therapy in which a Belzutifan is being administered and help to bring some additional data in the setting. Obviously a lot of work is still needed in terms of like additional data and larger cohorts really to evaluate Belzutifan and try to further investigate the efficacy of this drug and its safety and, you know, a real-world setting in a setting or another.
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